Westbury, NY

Sr. ENGINEER: R & D MEDICAL DEVICEProduct Development ManagerApplicable new product development work experience (6-12 years) in FDA regulated medical device/pharma environment using stage-gate product development processAdvanced degree (MS or Ph.D.) may be substituted for work experienceKnowledge of metal and plastic injections molding and FEA analysis is a plusResponsibilities:lead concept to launch of New Product Development and existing product improvement initiatives.responsible for development of specifications, managing risks, leading design and V&V activities.The scope of the work will be of a complex technical nature requiring investigation of new processes and technologies, and application of advanced engineering design methodologies in a FDA regulated environment.will be responsible for leading and executing technical activities necessary to complete major projects or several small projects.work in a cross-functional team environment and require supervision and mentoring of junior engineers.Identifies and analyzes design problems to achieve optimal solutions that satisfy technical requirements using both internal and external technical resourcesFormulates new, innovation approaches to solve technical problems on a consistent basisUses engineering and quality process improvements that impact the business via use of best industry practices (six sigma design methodologies preferred)Leads development of product specifications, risk documents and conduct technical and design reviewsContributes to the creation and maintenance of Design History FilesInsures project deliverables to meet global requirements (Regulatory, Corporate, Notified Body, etc., as required)Supports and participates during internal and external audits / inspections as needed

Requirements:BS in Mechanical/Biomedical EngineeringApplicable new product development work experience (6-12 years) in FDA regulated medical device/pharma environment using stage-gate product development processAdvanced degree (MS or Ph.D.) may be substituted for work experienceKnowledge of metal and plastic injections molding and FEA analysis is a plusDetailed oriented, possesses excellent documentation skillsExperience with building experimental test set-ups to characterize and assess functional performance of medical productsDemonstrated ability to solve complex design and engineering problems with minimal assistance, while drawing inputs from multiple and varied functions (i.e. Manufacturing, Quality, Regulatory, Clinical Development, etc.)Strong engineering investigative and analytical problem solving skillsAbility to solve for engineering projects with substantial complexity and scopeProven communication skills and ability to perform within a cross-functional team environmentPossess organization, communication, and interpersonal abilitiesBS degree in Mechanical or Biomedical Engineering required.Masters or Ph.D. degree preferredSix Sigma Black Belt preferredIMMEDIATE INTERVIEW!

Senior Product Development Manager, Project Manager: Medical Device

5-10 years of product development and project management experience in a medical device/ pharma environment.PMP certification through PMI is a plus.Working knowledge in Microsoft Project.Prior applicable medical device product development experience.Working knowledge of ISO and FDA guidelines as they apply to Product Development/Design ControlResponsibilities:Project Manager will be responsible for delivery and launch of medical devices and services to the market via cross functional project team coordination.The scope and scale of projects will range from minor functional enhancements to breakthrough products ranging from mechanical to technological in nature.New innovations may either be developed internally, or in collaboration with external partners and suppliers.support small to medium size project teams consisting of a representative(s) from R&D, Quality Engineering, Marketing, Regulatory, Purchasing/Supply Chain, Operations, Finance and Manufacturing.organizing cross functional team activities which include project schedule creation, project meetings, publishing detailed minutes consisting of action items and deliverables, while monitoring progress against the schedule.monitor team progress, ensuring that required technical interfaces to support the project are included to support the completion of project tasks and meeting project goals.Partners with Marketing, Clinical Development and Professional services functions to deeply understand the application and end use of family of orthodontic medical devices and services.Uses this understanding to be the Voice-of-the-Customer/business while interfacing with project teams and external partnersAligns specific project(s) to the global product development strategy and ensures compliance and divisional level proceduresAssist with project timeline and deliverables from project initiation stage to launch, including participating in cross-functional meetings outside of regularly scheduled meetings where necessaryPlans projects, directs and coordinates the efforts of engineers and non-technical project team membersManage timelines and responsibilities of select projectsConducts project meetings and design reviewsPublishes project action items and meeting minutes which track deliverables and open items.Create and implement metrics and communication to ensure team commitments (scope, project plan, resources) are met and communicated in a timely manner.Help ensure that products are launched on time and meet established goals and objectives (per project plan) to support goals of the organizationDevelops and maintains program plans and communicate program status to management and internal teamsDrives to keep resources on task and on schedule, manage change, understand technical issues and ensure that they get prioritized, highlighted, addressed and resolved in a timely mannerAssist coworkers where possible in project tasks.Provides regular updates to all Stakeholders on project status and progress being madeCreates and maintains Project File/(DHF).Insures project deliverables meet global requirements (Regulatory, Corporate, Notified Body, etc., as required).

REQUIREMENTS:Graduate or undergraduate degree in Biomedical or Mechanical Engineering5-10 years of product development and project management experience in a medical device/pharma environment.PMP certification through PMI is a plus.Working knowledge in Microsoft Project.Prior applicable medical device product development experience.Working knowledge of ISO and FDA guidelines as they apply to Product Development/Design ControlShould also possess strong leadership and team building skills, along with excellent organization, communication and interpersonal abilities.Able to travel for successful completion of projectsBS degree in Engineering (Biomedical or Mechanical) required.Master's degree preferredIMMEDIATE INTERVIEW!PLEASE EMAIL YOUR RESUME IN WORD FORMAT AND CURRENT BASE SALARY REQUIREMENTS ASAP: darrenf AT rtijobs dot com

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